Asteria Health Recalls Estradiol 15 mg Sterile Pellets Due to Potential Metal Contamination

Source: FDA · United States

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F.H. INVESTMENTS, Inc. (dba Asteria Health) is voluntarily recalling 14,848 Estradiol 15 mg sterile pellets nationwide due to the potential presence of metal particulate matter.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on February 24, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

F.H. INVESTMENTS, Inc., doing business as Asteria Health, has initiated a voluntary recall of Estradiol 15 mg sterile pellets. The recall was prompted by the potential presence of a foreign substance, specifically metal particulate matter, within the product. This Class II recall was officially classified by the FDA on February 11, 2026.

Which Products Are Affected

The recall affects 14,848 units of ESTRADIOL, 15 mg, 1 Sterile Pellet. The product is identified by NDC 79559-3015-32 and was distributed nationwide in the United States. The following lot numbers and expiration dates are included in the recall:

  • Lot#: 253000118, Exp. 02/21/2026
  • Lot#: 253000145, Exp. 08/02/2026
  • Lot#: 253000146, Exp. 06/30/2026
  • Lot#: 253000167, Exp. 09/23/2026

What You Should Do

Healthcare providers and consumers should immediately stop using the affected lots. Asteria Health began notifying customers of the issue via letter on January 26, 2026. For information regarding product returns or to report concerns, contact the firm at 432 Industrial Ln, Birmingham, AL 35211.

Why This Matters

The presence of metal particulate matter in a sterile drug product intended for administration poses a serious health risk, as it can lead to internal injury or adverse physiological reactions.

Source

Recall information provided by the FDA (Recall Number: D-0310-2026).

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
F.H. INVESTMENTS, Inc. (dba Asteria Health) is voluntarily recalling 14,848 Estradiol 15 mg sterile pellets nationwide due to the potential presence of metal particulate matter.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.